CN104039389A - Implantable device with an insulating layer - Google Patents
Implantable device with an insulating layer Download PDFInfo
- Publication number
- CN104039389A CN104039389A CN201280051373.0A CN201280051373A CN104039389A CN 104039389 A CN104039389 A CN 104039389A CN 201280051373 A CN201280051373 A CN 201280051373A CN 104039389 A CN104039389 A CN 104039389A
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- Prior art keywords
- coating
- housing
- liquid phase
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- polymer
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/28—Materials for coating prostheses
- A61L27/34—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/37512—Pacemakers
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D1/00—Processes for applying liquids or other fluent materials
- B05D1/02—Processes for applying liquids or other fluent materials performed by spraying
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D1/00—Processes for applying liquids or other fluent materials
- B05D1/18—Processes for applying liquids or other fluent materials performed by dipping
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05D3/00—Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials
- B05D3/10—Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials by other chemical means
-
- H—ELECTRICITY
- H05—ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
- H05K—PRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
- H05K7/00—Constructional details common to different types of electric apparatus
- H05K7/02—Arrangements of circuit components or wiring on supporting structure
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49002—Electrical device making
Abstract
The invention relates to a device (100) containing: a housing (110) with an inner surface (160) and an outer surface (170); and an electronic unit (130, 140, 180); wherein the housing (110) at least partly surrounds the electronic unit (180); at least one part of the inner surface (160) of the housing (110) has an electrically insulating coating (120) which contains at least 30 wt.% of a polymer and which comprises a coating surface (150) that faces the inner surface (160); and the inner surface (160) and the coating surface (150) are connected to each other.
Description
Technical field
The device that the present invention relates to implant, such as the field of cardiac pacemaker or defibrillator and different assembly thereof.Especially the present invention relates to a kind of device with casing liner that can implant, described casing liner is configured for has extra high impulsive force.In addition, the present invention relates to a kind of for the method for such device and a kind of for using the method for such device is provided.
Background technology
From known in the state of the art that can implant, for the device of different applicable cases.Therefore, except can, the defibrillator (Defibrillator) and cardiac pacemaker (Herzschnittmacher) described in the article " cardiac pacemaker therapy and defibrillator therapy: indication-planning-nurse more afterwards " using aspect treatment, delivered by people such as editor Gerd Fr hlig in for the publication of ISBN 9783131171818 at the Stuttgart Thieme publishing house document number of 2005 such as picture, also having the device that can implant, diagnose.The common ground of these devices is that they not only have the member of electronics but also have mechanical member.Because described device should be implanted in the health such as user, so at least should obtaining covering with respect to body fluid together with its responsive member, protects the member of described electronics.
Because the device great majority of described medical treatment are completely implanted, so they typically have battery for the power supply of himself.But also it is contemplated that, by inductive loop by electric energy transmitting to the described device that can implant.In any case, significant and be often also necessary, protect electronic unit to prevent dampness and protect on the other hand health to prevent unexpected electric current on the one hand.In order to ensure this insulating effect, between the housing of described device and the member of described electronics, there is as a rule the lining of isolation.
At present such as the lining of this isolation is sticked in cardiac pacemaker or defibrillator (ICD-can implant, cardioverter defibrillator) with hands.This very expensive and trouble.In addition exist following risk: correctly do not paste described thin film or described thin film and in the time pasting, slide and therefore do not reach that it is original, cover the meaning of protecting.In addition, may produce electric bridge due to the bubble between described housing and described lining.This causes following situation: the impulsive force reaching by means of pasted lining may be less than 2kV.
If the especially described device that can implant have cause member rising, electronics of voltage or the member group of electronics, such as defibrillator, so importantly, described member or described member group and the described device that can implant, and the housing of Body contact between ensured suitable insulation.Otherwise can in the health that comprises the described device that can implant, there is unexpected and the serious electroshock (Stromschlag) of consequence.
Summary of the invention
Therefore, task of the present invention is to overcome at least in part at least one shortcoming in the shortcoming producing from prior art.
In addition, task of the present invention is, a kind of device is provided, and this device can provide maximum protection and safety and meet the requirement of the medical device for implanting at this for user.
In addition, a task of the present invention is, can in such device, produce the member, that can reproduce of described electronics and enough lasting insulation effect, especially provide described device, identical or better impact strength with essential coating, less locus demand.
Another task of the present invention is, improve in implant, for member, the especially high pressure member impact strength that protect, housing to user and electricity.In this task should be also, the method for the device for the manufacture of such is optimized, method be that it can be realized for advantageously and can reproduce the feasible program of manufacturing described device.
The present invention solves one of aforementioned task with being characterized as of independent claims and contributes.Of the present invention, can individually or to combine arbitrarily improvement project realization, favourable obtain in the dependent claims description.
In first aspect, the present invention relates to a kind of device, this device comprises:
-housing, this housing has inner surface and outer surface;
-electronic unit,
Wherein said housing surrounds described electronic unit at least in part; That at least a portion of the inner surface of wherein said housing has is a polymer that comprises at least 30 weight percent points, electric insulation, be provided with the coating towards the coating surface of described inner surface; Wherein said inner surface and described coating surface interconnect.
Described device can be for different purposes.Preferably relate to a kind of device of medical treatment, relate in particular to a kind of device that can implant, medical treatment.The device of medical treatment refers in particular to a kind of device, and this device has medical function, such as treatment, diagnosis or the function of surgery.Device that can implant, medical treatment refers to a kind of device of medical treatment, and the device of this medical treatment at least can partly be put in the body of user.In addition, it should bear medical function, such as diagnosis, surgery or treatment function.For this purpose, described device can have a kind of special structure, such as special shape, for disturb as few as possible user in the time carrying.In addition, can so form the described device that can implant, make this device in the time putting it into and carry, disturb as few as possible and affect the health of user.This is such as realizing in the following manner: described device have such as the shape through rounding, outside and with the contact surface of the Body contact of user such as being made by biocompatible material.
Described by device of the present invention also can be configured to " active implantable medical device(active implantable medical devices AIMD) " and especially preferable configuration be therapy equipment.The function of especially described medical treatment can have at least one actuator function, for described actuator function, by means of at least one actuator, at least one stimulation, the especially stimulation of electricity is coated on bodily tissue.
The concept of active implantable medical device-be also referred to as AIMD-comprises all devices that medically can implant in principle, and described device can be transmitted to electric signal the systemic part of user and/or can be received by a systemic part for user from especially airtight the housing sealing.Therefore, the concept of described active implantable medical device especially comprise cardiac pacemaker, cochlea-implant, the cardioverter/defibrillator (ICD) that can implant, neural-, brain-, organ-or muscle stimulator and the monitoring instrument that can implant, sonifer, retina-implant (Retina-Implantate), the pump that can implant, artificial heart, bone growth stimulator, prostate implant, stomach-implant or similar articles for medicament.
Should so select the shape and size of the housing of described device, make it in the time implanting at least a portion of described device, not hinder user.In addition, described housing should have a kind of shape, thereby can save as far as possible locational space settles the member of described device, such as battery, controller, capacitor and/or cable.If relate to a kind ofly to be encased in device in body completely, such as instrument, especially ICD treatment or diagnosis, the volume so described housing being surrounded is in from 0.1 to 50cm
3scope in, preferably in from 0.5 to 30cm
3scope in, particularly preferably in from 5 to 20cm
3scope in.The width of the housing of described device and length can be respectively in from 1 to 10cm scopes, preferably in from 3 to 7cm scope at this.Described height is often in from 0.4 to 2cm scope and preferably in from 0.5 to 1.5cm scope.The shape of described housing can be shape arbitrarily.Such as described shape can be to have corner angle, circular, oval-shaped or taper.The housing of preferred described device does not have sharp-pointed seamed edge and corner angle.Described housing can be made up of one or more parts.Preferred described housing is made up of the parts of two shellies.Described housing should be suitable for surrounding at least in part other ingredient of described device.Described housing can have one or more opening, and described opening allows the ingredient of described device to import in described housing.Such as cable being guided to outside from enclosure interior through the opening of described housing.Preferred described housing is at least outwards sealed hermetically in the time using described device.Therefore, described housing parts is also received the insulated sleeve of the contact among being electrically connected with cardiac muscle.
Described housing has inner surface and outer surface according to the present invention.At this, the material of described inner surface and outer surface needn't be identical, but also can be identical.Described inner surface and outer surface can interconnect.Described inner surface is at other the member using in the state of described device towards described device.Described outer surface after implanting towards the health of user and can contact with the health of user at least in part.In the state of not implanting, described outer surface is the ingredient of described device dorsad.
In addition, described have electronic unit by device of the present invention.This electronic unit can comprise the molectron of one or more electronics, and described molectron can produce, stores, conducts or consume electric charge.Such as described electronic unit can be selected from the group being made up of following material: the combination of battery, capacitor, control unit and cable or wherein at least two parts.According to the present invention, described housing surrounds described electronic unit at least in part.Therefore, can be arranged in the inside of described housing and another part of this molectron and can be arranged in the outside of described housing such as a part for molectron battery or other electronics.As an alternative or additional project, the molectron of one or more other electronics can partially or fully be arranged in the inside of described housing.Preferred described electronic unit is arranged in the inside of described housing completely, is namely surrounded by described inner surface.
At least a portion of the inner surface of described housing has and comprises at least 30 weight percent points, preferably at least 40 weight percent points, coating polymer, electric insulation of at least 50 weight percent points particularly preferably according to the present invention.The coating of described electric insulation has again the coating surface towards the inner surface of described housing.According to the present invention, the inner surface of described housing and described coating surface interconnect.According to the present invention, coating refers to layer or continuous rete continuous in the scope in connected region.Described coating surface is the surface of described coating according to the present invention, this surface towards the inner surface of described housing and with the inner surface of described housing among contacting.
" connection " can refer to according to the present invention, and the part of the part of described coating surface and the inner surface of described housing is among directly or indirectly contacting, and these two parts should couple together, and wherein directly contact is preferred.Directly contact should refer to, described coating surface is directly being followed the inner surface of described housing.If do not use and increase the material that adheres to or layer between the layer of electric insulation and inner surface, especially occur above-mentioned situation (directly contact).On the contrary, in the time that described coating is being followed the inner surface of described housing indirectly, between described coating surface and described inner surface, be provided with one or more, preferably by the intermediate layer that increases adhesive agent, forms such as adhesive or wax.
Contact for described surface carries out by every kind the mode that two surfaces contact.Described contact is preferably by carrying out the coating of the form of liquid phase to this mode on the inner surface of described housing.According to the present invention, can be called liquid phase by mobile material by all.Belong to liquid phase such as be liquid solution, such as dissolving polymer in solvent or liquid mixture, such as the solvent-free paint vehicle with monomer, cross-linking agent and initiator substantially, at least two kinds of a kind of uniform, liquid mixture of chemical material production or disperse means (Dispersionen) or the very different powder of composition for the solution of described liquid state, wherein for described disperse means, at least bi-material produces a kind of heterogeneous mixture.The coating of liquid phase can be by making the mode of liquid-phase precipitation on described inner surface or can being undertaken by the mode that described inner surface is impregnated in described liquid phase.Described precipitation process such as can be by coating with the form of liquid phase smear, roller coating, injection, roll extrusion or be ejected into process such on the inner surface of described housing.Preferably after contacting with the liquid phase in described coating, the inner surface of described housing carries out the change of state of described coating.This change of state causes following result: the solid phase that becomes the form of the coating of described electric insulation from described liquid phase.Described coating forms stable, especially membranaceous being connected at this with described housing.
Change of state such as the ingredient of liquid phase described in can referring in the time changing gradually the coating of electric insulation into, fixing on the inner surface of described housing.If such as the liquid phase of powder type being coated on the inner surface of described housing, that just can be by causing following result for the heat treatment of described powder: the ingredient fusion of described powder and the position on the inner surface of described housing is fixed on the inner surface of described housing and constructs planar layer structure by it.In the time forming described layer structure, described coating surface is connected with the inner surface of described housing, thereby between housing and the coating of electric insulation, produces a stable unit.This is also often called as paint vehicle.
As an alternative or additional project, can apply described coating with the form of solution or disperse means, wherein between housing and coating, form stable, especially membranaceous being connected described solution or disperse means are same after dry.Here, also after described coating is dry, the ingredient position of the coating of described electric insulation is fixed on the inner surface of described housing.In dry run or after dry, the ingredient of the coating of described electric insulation can be carried out chemical reaction to each other or with the inner surface of described housing.
Described connection procedure can be as already mentioned such as the chemical reaction of the ingredient of the inner surface of the ingredient by coating described liquid phase or electric insulation and described housing carries out.Described chemical reaction can carry out according to functional group on described coating surface on the inner surface of described housing or on these two.At this, the functional group of described coating surface can react with the ingredient of the inner surface of described housing and vice versa.As functional group, such as the molecular based of considering easily to react, such as hydrophilic group.Described functional group preferably can select from the group being made up of following Organic substance: two keys, especially vinyl (R
2c=CH-), pi-allyl (R
2c=CHCR
2) alkynyl (RC=C-), hydroxyl (OH), hydrogen sulfide base (SH ,-SH
2), ester group (COOR), acidic group (COOH), ether base (CHOR), amino (NH
2, NHR, NR
2), epoxy radicals (COC) and phosphate base (PO
3oH) combination or wherein.The intensity being connected between described coating surface and the inner surface of described housing can change according to the selection of the kind of described functional group and/or number.Described coating surface can be triggered or be accelerated by different measures from the reaction of described inner surface after described two Surface Contacts.Described measure is such as selecting from the group being made up of following measures: the preferably temperature in the scope of 60 to 120 DEG C of raising, convection current, light, especially IR or UV light and pressure or by wherein at least two combinations that measure forms.
In addition, the combined effect of the physics that is connected the inner surface by described coating surface and described housing of the inner surface of described coating surface and described housing is carried out.Such as described coating at least can a part be squeezed in the air pocket of inner surface of described housing in the time that this coating contacts with the inner surface of described housing.This can cause very firmly and to connect, described connection frequently as two surperficial bonding firmly.The combined effect of described physics is such as carrying out in the following manner: the coating of described electric insulation is contacted with the inner surface of described housing using the form of liquid solution, disperse means or as powder.The granularity that described liquid phase can have so low viscosity or described powder at this can be so little, makes in the air pocket of its inner surface that is squeezed into described housing and with after fixing.Described solidification process can be realized by different modes.Such as relating to a kind of liquid phase, the easy solid-state ingredient of volatilizing and leaving described liquid phase after evaporation of the solvent of this liquid phase.The example of this respect is the formation of enamelled coating.As an alternative or additional project, trigger chemical reaction after can be on the inner surface that described liquid phase is coated to described housing, described chemical reaction makes described coating such as the form with enamelled coating is hardened the covering surfaces in the situation that.In the time that the coating of the inner surface of described housing and described electric insulation is coupled together, such as a part for polymer can be cross-linked to each other or be cross-linked with other ingredient of described coating or with the ingredient of described inner surface.
In the preferred design of one, described electronic unit comprises capacitor.Particularly preferably, be cardiac pacemaker or the cardioverter-defibrillator (ICD) that can implant or be ICD ventricle or atrium-ventricle by device of the present invention.Cardiac pacemaker or ICD also comprise at least one battery and electrode except described capacitor.Described electrode not only can be for receive signal from tissue around, and can be for being transmitted in the electric pulse producing in described battery and/or in described capacitor, or for these two kinds of purposes.
Preferred described capacitor has the scope in from 50 to 1000 μ F, particularly preferably the scope in from 100 to 800 μ F, the electric capacity the scope in from 200 to 500 μ F more particularly preferably.These electric capacity are enough to be used in like such, the traditional ICD described in the Stuttgart Thieme publishing house document number of 2005 is the document " cardiac pacemaker therapy and defibrillator therapy: indication-planning-nursing more afterwards " of being delivered by people such as editor Gerd Fr hlig in ISBN 9783131171818 publications of operating ratio.Such as realizing the galvanic shock of the shock effect with 30 joules, described ICD sends to described shock effect described electrode and sends to thus heart thus.Such as can so designing described capacitor, make its can send have in from 500 to 1000V scope, preferably in from 600 to 900V scope, the particularly preferably current impulse in the voltage from 750 to 800V scope.
The described material that can comprise arbitrarily, especially have conducting power by the housing of device of the present invention.Preferably this housing is made up of a kind of material, and this material can should not implanted health wherein and breaks or can not stimulate or affect described health.In addition, the material of described housing should be enough to stablize, so that can be not impaired because of power in described device is put into health time.In addition, described material is being proposed to higher requirement aspect corrosion stability.Therefore, improve the described time of staying in vivo of pressing device of the present invention.Preferred described housing can only fine be out of shape, for preventing that in the process that uses described device the content of described device is subject to the impact of external force.In this respect, not only the material of conduction but also material non-conductive or fine conduction are all suitable.Such as the polymer of metal and conduction belongs to the material of described conduction.Such as the polymer of glass, pottery or electric insulation belongs to described material non-conductive or that fine conduct electricity.The material of preferred described housing is metal, the metal of especially selecting from the group being made up of following metal: platinum, titanium, ferrum and the alloy that comprises these metals.In the preferred design of one of described device, described device comprises at least 40 weight percent points, particularly preferably at least 70 weight percent points, the titanium of at least 90 weight percent points more particularly preferably with respect to described housing.Remaining maximum 60 weight percent point can be selected from the group being made up of following material: aluminum, vanadium, neodymium, niobium and polymer and by combination that wherein at least bi-material forms.Preferably relate to a kind of alloy of selecting from the group being formed by following material: 1 grade of titanium, 23 grades of titaniums, 2 grades of titaniums, particularly preferably relate to a kind of alloy with respect to described housing with the content of the titanium that is greater than 80 weight percent points.In addition, described alloy can be Ti6A14V alloy, is wherein preferably 6 weight percent points with respect to aluminum content described in described alloy and described content of vanadium is preferably 4 weight percent points.In another preferred embodiment, can use a kind of material for described housing, this material comprise at least 50 weight percent points, preferably at least 60 weight percent points and particularly preferably the ferrum and scope in from 15 to 30 weight percent points of at least 70 weight percent points, preferred alloying metal the scope in from 20 to 27 weight percent points, that be different from ferrum the scope in from 17 to 28 weight percent points and particularly preferably, the summation of wherein said weight percent point is correspondingly 100.In addition, described housing can be made up of a kind of material, and this material comprises with respect to described housing and be greater than 50 weight percent points, be preferably greater than 60 weight percent points, be particularly preferably greater than the ferrum of 70 weight percent points.In addition, described housing can comprise the material of selecting the group from being made up of following material: chromium, nickel, magnesium, silicon and carbon.Preferably relate to a kind of alloy of selecting from the group being formed by following material: high-quality steel SS 304L and SS 316L.
The polymer being included in described coating can be every kind of polymer that is suitable for making the stable connection between inner surface and the described coating surface of described housing.In addition, described polymer can be born the function that other ingredient of the coating of described electric insulation is combined.Described polymer can be configured to heat cured or thermoplastic structure.Heat cured polymer generally has at least in part cross-linked structure below polymer chain, and thermoplastic polymer does not have or only have very little cross-linked structure below described polymer chain.
As polymer, can use all is solid-state polymer under room temperature or body temperature.The coating of preferred described electric insulation comprises especially to be selected from the group being made up of following material, synthetic polymer: polyethylene (PE), polypropylene (PP), polrvinyl chloride (PVC), polyester, such as Merlon (PC) or polyethylene terephthalate (PET), polystyrene (PS), polytetrafluoroethylene (PTFE), polymethyl methacrylate (PMMA), polyamide, polyimides, Polyethylene Glycol (PEG) and silicone or the combination being formed by these materials.In the preferred design of one of described device, described polymer is selected from the group being made up of following material: comprise acrylates, alkyd resins, polyester-imide, polyamide-imide and silicone or the wherein at least combination of bi-material.In a kind of design of the present invention, described polyamide-imide or described polyester-imide can be being greater than the degree of 70 weight percent points, particularly preferably to be greater than the degree imidization of 85 weight percent points.
Other ingredient of described coating can be every kind of material.Preferably these materials have the characteristic of electric insulation.Such as other ingredient of described coating can comprise binding agent, pigment or other additive.Described other ingredient can be selected from the group being made up of following material: glass, pottery, polymer, organically dyestuff, inorganic dyestuff and white carbon black and the wherein at least combination of bi-material.First described coating has the function of with respect to the environment of the member of described housing and described electronics, the member of described electronics being carried out electric insulation.
In the preferred design of one of described device, described coating has the scope in from 1 to 100 μ m, preferably the scope in from 10 to 80 μ m, the thickness the scope in from 30 to 60 μ m particularly preferably.In order to produce the coating with such size, preferably, as already mentioned by make liquid phase contact with the inner surface of described housing this mode as after also will be at length manufacture described coating described for described manufacture method.
Described device preferably has in from 3 to 30cm
3scope in, particularly preferably in from 5 to 25cm
3scope in, more particularly preferably in from 10 to 20cm
3scope in volume.For can be for the ingredient of described device provides space as much as possible, the largest portion of the volume of described device be hollow.The cavity so obtaining preferably almost has the volume identical with whole device.The cavity of described device preferably so forms, thereby produces a unique cavity, the ingredient that can save as far as possible locational space settle described device in this cavity.As an alternative, also can in described device, construct multiple cavitys.
In addition, preferably a kind of device, for this device, the coating of described insulation has in from 1 to 30cm
2scope in, preferably in from 5 to 25cm
2scope in and particularly preferably in from 10 to 20cm
2scope in area.The whole inner surface of preferred described housing is connected with the coating of described insulation.At least a portion of described outer surface can be connected with the coating of electric insulation equally.This can be the coating identical with coating on the inner surface of described housing.
In the preferred design of one of described device, through the breakdown voltage of the coating of described insulation be 2kV and higher, be preferably 4kV and higher, and be especially preferably 7kV and higher.Described breakdown voltage for described housing thereby be also described device other member, with respect to the yardstick of the insulation of the environment of described housing.Described breakdown voltage shows, from which kind of is loaded into the voltage on the housing of described device by electric current the coating delivery by described housing and described insulation to the inside of described device and vice versa.For the device that should be implanted in health, the breakdown voltage of the housing of described device should be high as much as possible, for not only preventing that described health is subject to unexpected electric shock, but also for preventing that the member of described device is subject to outside interference.The level of described breakdown voltage can affect by the composition of the coating of described electric insulation and thickness.If the coating of described electric insulation has the assembly of the electric insulation of higher share, such as the polymer of electric insulation or the assembly of other electric insulation, so described breakdown voltage can be very high.If being connected between the inner surface of described housing and described coating surface is highly stable and even, so described layer can be constructed than thin in the time that described connection is inhomogeneous in the situation that breakdown voltage is identical.
In another aspect of the present invention, a kind of method for the manufacture of device is described, the method comprises the following steps:
A., a housing with inner surface and outer surface is provided;
B. by a coating polymer that formed by liquid phase, that comprise at least 30 weight percent points, electric insulation at least a portion of described inner surface;
C. electronic unit is put in described housing, wherein said housing surrounds described electronic unit at least in part.
Be equally applicable to described by the method for the manufacture of described device of the present invention all about the explanation of the design for described device.The housing of described device can have and be described situation about explaining by device of the present invention identical material, shape and performance above.Described housing has inner surface and outer surface, and described inner surface and outer surface can be as above for described device form described.Providing of described housing can be carried out in diversified mode.Such as described housing being clamped in support or so and being kept by support with its outer surface, make it obtain space and fix.As an alternative or additional project, described housing can be above movable bearing, if described bearing is provided.Described housing is preferably so provided, thereby can freely approaches described inner surface." freely approaching " refers to according to the present invention, and whole inner surface is for approaching for the additional device of the coating that applies described electric insulation.Especially described inner surface should be able to be with describedly encountering for applying the additional device of coating of electric insulation, especially contact.
According to the present invention by the coating of described electric insulation by liquid phase such as the form of the solution with liquid or disperse means is coated at least a portion of inner surface of described housing.Described liquid phase can comprise solid-state ingredient.As an alternative or additional project, described liquid phase can be also emulsion or disperse means.As described in being, device is mentioned, described liquid phase can comprise multiple components.Described liquid phase comprises polymer or polyblend.Described polymer can so form and have and be the identical performance of the described situation of described device.Described liquid phase preferably comprises a kind of solvent, and this solvent can be selected from the group being made up of following material: the combination of water, organically solvent or these materials.Described organic solvent is preferably selected from the group being made up of following material: ether, ethanol, Hydrocarbon and acetone or by mixture that wherein at least bi-material forms.Except described polymer, described liquid phase also can have solid-state, especially pulverous ingredient.Described solid-state ingredient is such as being binding agent, white carbon black or pigment.
Described liquid phase can be coated on described inner surface by every kind of methods, and described inner surface is suitable for constructing from the teeth outwards thin as far as possible layer with accurate as far as possible layer thickness profile.Have the scope in from 0.1 to 500 μ m, preferably the scope in from 1 to 200 μ m, particularly preferably construct thickness, plane the scope in from 10 to 100 μ m can be called as thinner layer.In the preferred design of one of described method, by from by precipitate or flood or these two the group constituting the process selected carry out.
According to the present invention, precipitation refers to, makes described liquid-phase precipitation from the teeth outwards by additional device.This can be undertaken by different additional devices.Described liquid phase is such as being sprayed or be ejected on surface by nozzle or valve in the time precipitate.As an alternative or additional project, described liquid phase is such as applying or be rolled on described surface by roller or cylinder.As spraying or injection method, such as known by opening, such as nozzle or valve carry out micro-metering or ink jet printing.Pressure can be coated in liquid phase to be applied, or described liquid phase is coated on described surface by described opening in the mode of drippage by means of gravity.Preferably make described liquid phase, such as the form of the enamelled coating with liquid is deposited on described surface under pressure.
As nozzle or valve, such as using piezo electric valve as known in being used in ink-jet printer or pneumatic valve.These valves have to form and need the performance of share of liquid phase of precipitation, and described share is then preferably deposited on described surface under pressure.Described share preferably has in from 0.1 to 500nl scope, particularly preferably in the volume from 10 to 100nl scope.There is surface to be coated should preferably there is the temperature in the scope of from 30 to 60 DEG C.Have the temperature of liquid phase to be applied should be preferably in the scope of from 20 to 60 DEG C, particularly preferably in the scope of from 20 to 35 DEG C.Described liquid phase is liquid or pulverous coating material preferably, and this coating material is coated to compared with unfertile land on article and by process chemistry or physics, such as the evaporation of solvent is configured to continuous, solid-state rete.Described liquid phase is made up of binding agent, pigment, solvent, filler and additive conventionally, wherein can the various components of optional use.The liquid phase with a kind of like this composition is often also referred to as paint vehicle.As binding agent, can use every kind of binding agent known for the purposes of the precipitation of coating.Preferred binding agent is as the polymer as described in also wanting below.As pigment, can use every kind of pigment that is suitable for coating procedure.Can use equally all solvent, filler and additives that are suitable for coating procedure.In the time of the liquid-phase precipitation of the form of liquid solution or disperse means, described surface can contact with described liquid phase completely or partially.Select how littlely by the amount of the liquid phase of selecting in the time spraying or spray, the very thin sample of described coating can be coated on the inner surface of described housing.By described precipitation, can avoid extraly described housing, should not contact with coating by the cated parts of tool.In when dipping, be necessary as a rule, parts that should not moistening are hidden.
The liquid phase of the form of described that should use in order to be deposited on described surface, liquid paint vehicle should preferably have in from the scope of 50 to 400mPas (micropascal seconds), preferably in the viscosity from 50 to 200mPas scope.The described liquid phase that needs precipitation should have in from 0.5 to 3g/cm
3scope in, preferably in from 0.8 to 1.9g/cm
3scope in density.Preferably, need precipitation liquid phase with respect to the gross mass of described liquid phase have the scope in from 10 to 80 weight percent points, the preferred solid share the scope in from 20 to 50 weight percent points.
In when dipping, make such as there being surface to be coated to pass from there is the pond of liquid phase of the application of needing.As an alternative, also can be as using when dip-coating (Dip-Coating) by described surface impregnation in described liquid phase and again it is therefrom pulled out.By dipping repeatedly, can realize the different thickness of described coating.In addition, the thickness of described coating depend on as mentioned above selection described liquid phase or other parameter, such as described liquid phase or described inner surface, in the temperature of implementing when coating process.
In the preferred design of one of described method, apply described liquid phase by the coating opening being arranged on described inner surface, wherein described liquid phase is coated on described surface with the form of drop.Wherein can the order of described drippage be selected so highly, thereby almost produce the jet of liquid phase.If apply described liquid phase with the form of drop, described drop can be coated on the surface of described housing so abreast, make whole desired surface wetted.Obtain thus the continuous rete of liquid phase, described rete can harden into the coating of electric insulation subsequently.The distribution of described drop otherwise can by described nozzle, carry out with respect to the motion of described housing, or can by described housing, carry out with respect to the motion of described nozzle.Described drop can preferably so closely be arranged side by side, and described liquid phase is assembled on the border of described drop, and surface cambial form, continuous like this.By means of by the mode of dripping to apply, some regions of the optional inner surface that can make described housing contact with coating more or less.Not only can be by the size of described drop but also can be by thickness described nozzle, change described coating with respect to the speed of the motion of described housing.Therefore coating can be set in some region yet, if expect so words.
One preferred embodiment in, apply described liquid phase by the coating opening being arranged on above described inner surface, wherein said coating opening and described surface interconnect by described liquid phase.By the inner surface of described liquid phase and described housing being coupled together to this mode in the time that described liquid phase is coated on described surface, can avoid described liquid phase to separate on described surface.Can realize thus this point: very uniform rete can be coated on described surface.By described coating opening, with being connected of inner surface of described housing can realize this point: by described liquidus curve strip be coated on the inner surface of described housing.
These two kinds of above-mentioned methods, not only described by the method for dripping to apply but also the coating method of described interconnection system, also all known as micro-metering (Mikro-Dosierung).Described micro-metering has special characteristic, thus can with simple mode by the different thickness of described coating be coated to object, such as being on the inner surface of described housing here.Described coating opening can have every kind of conceivable shape and size.It is such as can be to have by coating opening circle, oval-shaped, that have the shape of selecting in the group constituting corner angle and star or wherein.
Described coating opening can have from 10 μ m to 1mm, the preferred diameter from 100 μ m to 0.5mm.In addition, described opening can have from 10 μ m
2to 1mm
2, preferably in from 0.01mm
2to 0.5mm
2scope in, particularly preferably in 0.05mm
2to 0.25mm
2scope in area.Preferably by means of in from 1100 to 5000mbar scope, preferably in from 1100 to 4000mbar scope, particularly preferably described liquid phase is coated on described surface by described nozzle in the pressure from 1100 to 3000mbar scope.As a rule, can be adjusted in the pressure on described coating unit.
For applying the flexible program of described liquid phase, can use printing process as another kind.The salient point of described printing process is to shift liquid phase by carrier.Preferred described carrier can be absorbed in described liquid phase at least in part wherein and be come out again when with another Surface Contact.Such as in flexible printing method, be provided with have need application roller liquid phase, that have inlet capacity, this roller is expressed on surface to be coated or make its described have on surface to be coated roll.By the design of described nozzle, roller or cylinder and described in have viscosity and the pluripolarity of liquid phase to be applied, the layer of different-thickness can be coated on desired surface.
The described liquid phase being applied in coating process on described inner surface, comprises a kind of polymer according to the present invention.Polymer in described liquid phase can be also the mixture of multiple polymers, so select the concentration of described polymer, make the electric insulating barrier that formed by it with respect to the quality pack of described coating containing at least 30 weight percent points, preferably at least 40 weight percent points, at least 50 weight percent points particularly preferably.As polymer, can use all is solid-state polymer under room temperature or body temperature.The coating of preferred described electric insulation comprises synthetic polymer, such as polyethylene (PE), polypropylene (PP), polrvinyl chloride (PVC), polyester, such as Merlon (PC) or polyethylene terephthalate (PET), polystyrene (PS), polytetrafluoroethylene (PTFE), polymethyl methacrylate (PMMA), polyamide, polyimides, Polyethylene Glycol (PEG) and silicone or the combination that is made up of these materials.In the preferred design of one of described method, described polymer is selected from the group being made up of following material: acrylate, alkyd resins, polyester-imide, polyamide-imide or silicone or the wherein at least combination of bi-material.In a kind of design of the present invention, described polyester-imide, polyamide-imide can be being greater than the degree of 70 weight percent points, particularly preferably to be greater than the degree imidization of 85 weight percent points.
After immediately on the inner surface that described liquid phase is coated to described housing, can make the inner surface of described housing stand dry run.This dry run is for carrying out dried to the coating of described electric insulation fast and equably.In the preferred design of one of described method, the coating of described electric insulation consists of radiation or convection current or these two.In the time of the described coating of structure, can carry out dry run, this dry run can be accelerated and be optimized by different supportive measures.This dry run is such as can be with in the scope of from 25 to 200 DEG C, preferably in the scope of from 40 to 150 DEG C, particularly preferably the temperature in the scope of from 50 to 80 DEG C is carried out.Described temperature can also can at random change in dry run in mentioned scope.
As replacement scheme or the additional project of the temperature improving, coated liquid phase also can stand the radiation of carrying out with electromagnetic wave, for supporting layer forming process.This can be the radiation in whole available wave-length coverage.Preferably use the radiation in ultraviolet or ultrared wave-length coverage, that is to say and have in from 800 to 2000nm scope or in from 200 to 400nm scope, preferably in the radiation from 800 to 1500nm scope or in the wavelength from 300 to 400nm scope.
By use convection current or radiation of the form such as the temperature improving, the ratio of solvent of described liquid phase is evaporation quickly in the situation that there is no these measures.Also only solid-state ingredient is stayed on described inner surface with the form of coating thus.In addition, carry out in dry process in the temperature that uses radiation or raising, extraly in the internal trigger cross-linking reaction of described polymer.Can realize thus this point: described coating structure obtains hard and even especially.Preferably solid-state layer ingredient, continuous of described coating.The coating of described electric insulation has the characteristic of constructing continuous layer, and described continuous layer itself is stood lip-deep power higher, that act on described process coating.Therefore can use higher shearing or frictional force, and described coating is not damaged." damaged " variation of the thickness that not only refers to described coating and refer to described coating shape variation and refer in particular to the variation of the function of described coating.According to the present invention, coating is not damaged, if it is engaging (Eingriff) afterwards or lost below 10% of its original breakdown voltage in the time that finish the service life of described device.
By means of described coating method, can obtain in the scope being between 1 and 100 μ m, preferably in the scope between 10 and 80 μ m, particularly preferably in the thickness of the coating between 30 and 60 μ m.Also it is contemplated that, take the combination of intermediate processing and dipping method.In addition can carry out twice, and apply more frequently.Therefore, also can successively or simultaneously apply the coating with different coating materials.
Preferably, make at least a portion of the inner surface of described housing before coating, stand chemical cleaning process.By such cleaning process, can realize this point: at least described inner surface has a kind of state, described inner surface is connected with described coating more easily or is connected with described coating more enduringly or more securely with this state.Therefore, the surface of described inner surface can be by selected coating being configured in better on which bottom surface and processed must be Paint Gloss or more coarse.In the time cleaning, can be by the surface ratio of described inner surface as processed more loosely, make described liquid phase together with coating can be adhered to described inner surface when described coating better.Can in described inner surface, form air pocket by described cleaning process, described liquid phase can be squeezed in described air pocket in the time of coating.In the time of described coating sclerosis, realize being in this way very connected of strengthening with described inner surface.The cleaning of chemistry can with the chemical agent that provides of promising such purposes implement.The cleaning process of preferred described chemistry can be selected from the group being made up of following process: the cleaning of thermokalite, the flushing of carrying out with organic solvent, corrosion or the wherein combination of at least two kinds of methods.In the time carrying out the cleaning of thermokalite, the alkali liquor such as selecting the group that can use from being formed by following material: sodium hydroxide (NaOH), potassium hydroxide (KOH), potassium phosphate (K
3pO
4) and hydrophosphate or the wherein combination of at least two kinds of chemical agents.The concentration of described alkali liquor preferably the scope in from 0.1 to 5 volume percentage point, preferably the scope in from 1 to 5 volume percentage point, particularly preferably the scope in from 2 to 3 volume percentage points.Can also be extraly to mix in different alkali liquor surfactant, especially anion, cationic or non-ionic surfactant or the combination that formed by it.As organic solvent, such as using acetone, ethanol or Hydrocarbon.As ethanol, the mixture that can preferably use ethanol or isopropyl alcohol or be formed by it.Described ethanol can mix with different concentration use at this with water.The mixture of preferred described ethanol or ethanol can use with the concentration in the scope in 70 to 100 volume percentage points with respect to total solution.As an alternative or additional project, also can corrode with acid.Here, first Fluohydric acid. (HF), ammonium acid fluoride (NH
4hF
2), hydrochloric acid (HCl), nitric acid (NHO
3) and sulphuric acid (H
2sO
4) or the combination being formed by it can be called as suitable caustic.These different detergents also can together or successively use in any order.
As an alternative or additional project, also can use mechanical cleaning process.The cleaning process of this machinery has the object identical with chemical cleaning process.In the preferred method of one, before the described coating of coating, make at least a portion of the inner surface of described housing stand mechanical cleaning process.Thus, by the object that should reach, also can as in chemical cleaning process, improve or reduce surperficial roughness.In the preferred method of one, the cleaning process of described machinery is selected from the group being made up of following methods: plasma cleaning, blasting treatment and bead clean or by wherein at least two kinds of combinations that method forms.Described plasma cleaning can preferably be implemented with oxygen/argon plasma.In blasting treatment, preferably use and there is d
50the scope in from 50 to 200 μ m the Al of average granularity
2o
3(aluminium sesquioxide), this Al
2o
3with in the pressure-acting from 1.5 to 5bar scope in described surface.In the time carrying out bead cleaning, use the big or small bead having the scope in from 50 to 200 μ m.
In another aspect of this invention, a kind of device is described, this device obtains according to method described above.
In addition, one aspect of the present invention is a kind of for implanting the method for illustrated device above, and the method comprises the following steps:
-described device is provided;
-open tissue;
-described device is put in opened tissue;
-if desired by described tissue closure.
All about the explanation of the design for described device be equally applicable to described by of the present invention, for the method for implanting device.Can be with every kind of form that can use by described device for described method.Provide the step of described device, such as arranging, described device is put into this step in applicator (Applikator), by means of described applicator, can described device be put in described tissue by user itself.This applicator in the process of application, open independently described tissue and described device is put into described in the tissue opened.After removing described applicator, described tissue is closed such as coming by means of adhesive bandage again, if be necessary like this.As an alternative, described step also can manually be carried out.Therefore, described device can with its original can with and the form that has Functional Capability provide.Also can in the packaging of sterilization, provide described device, this packaging can be opened before using described device.Opening such as also can be with being similar to the article of blade, such as scalpel carries out of described tissue.Just as possible closure, in the tissue of opening described in also can artificially described device being put into.
In addition, about described by the explanation of device of the present invention be equally correspondingly applicable to described by of the present invention, for generation of method of device and products thereof and for implanting the method by device of the present invention.This is particularly useful for the design in material and space.
Brief description of the drawings
Other details of the present invention and feature from below especially in conjunction with dependent claims to obtaining preferred embodiment description.At this, corresponding feature can itself individually or multiple form with combination to each other realize.The present invention is not limited to described embodiment.Described embodiment is schematically illustrated in the accompanying drawings.Reference numeral in each accompanying drawing, identical represents element identical or that function is identical or correspond to each other about its function at this.Accompanying drawing illustrates:
Fig. 1 is the vertical section of the schematic structure of the device that can implant;
Fig. 2 is the schematic structure for the application apparatus of described coating;
Fig. 3 is for illustrating for manufacturing by the chart of the step of device of the present invention, method; And
Fig. 4 is for illustrating for implanting by the chart of the step of device of the present invention, method.
Detailed description of the invention
In Fig. 1, schematically show the device 100 that can implant.This device 100 has housing 110, and this housing has inner surface 160 and outer surface 170.The inner surface 160 of described housing 110 is connected with the coating 120 of electronic isolation by described coating surface 150.This device forms by device of the present invention together with described, electronic unit 180 that form with capacitor 130 by battery 140.Described coating 120 is made up of the alkyd resins of the polymer with 45 weight percent points in such an embodiment.The thickness of the coating of described electronic isolation is 55 μ m in this case.In addition, described device 100 can also there is the member of the electrode that just do not illustrate and other electronics here, such as memory element or processor.
Figure 2 illustrates a kind of for liquid phase 218 being applied to 210 to the device on substrate 212.Described substrate 212 is representing a part for the inner surface 160 of Fig. 1 in this case.Nozzle 222 so arranges about the surface of described substrate 212, thereby can so apply described liquid phase 218, to can liquid film by sustainable existence between the surface of described substrate 212 and described nozzle.But, as an alternative, also can so select described nozzle 222, with respect to the spacing of described substrate 212, thereby described liquid phase 218 can be coated on described substrate with the form of drop.Install 210 with this and can apply equably in the following manner described liquid phase 218: described substrate 212 has obtained supporting in the mode that can move back and forth along reference coordinate 214.Thus such as the liquid phase of wire 218 being coated on described substrate 212.As an alternative, described nozzle 222 can be arranged in the mode that can move along this reference coordinate 214.By means of described control unit 216, can control the process that described liquid phase 218 is flowed to described nozzle 222 by carrier pipe 224.In order to change the pressure in the liquid phase 218 of described carrier pipe 224 inside, can pressure be coated in described liquid phase 218 by force applications mechanism 220.In such an embodiment, relate to a kind of liquid phase 218, this liquid phase comprises following component: the solvent crude naphtha (CAS#64742-48-9) of 55 volume percentage points, the alkyd resins of 45 volume percentage points.Described paint vehicle is the Elmotherm FS 190 of German Elantas GmbH company.Described liquid phase is coated on described substrate 212 by having a nozzle 222 with the coating opening 226 of the opening diameter of 0.3mm.
In Fig. 3, schematically show for the manufacture of by the flow process of the method for device 100 of the present invention.This method is such as for the manufacture of such device 100 as illustrated in fig. 1.First two housing components are provided, and these two housing components are coated from its medial surface respectively.Device Fig. 2, that be referred to below as applying device 210 is for aforementioned applications.In the first step 310 that housing 110 is provided, so location and fixing described housing 110, make at least described housing inner surface 160 can such as shown in figure 2 by coating auxiliary member, such as nozzle and valve approach, wherein said nozzle 222 is representing described coating auxiliary member.By means of described nozzle 222, can carry out the coating of the coating 120 of electric insulation described in second step 320-.Can use liquid phase 218 as previously described at this.Only also optional necessity, namely in optional third step 330, coated liquid phase is dried.This dry run has continued one hour in such an embodiment in the time that temperature is 80 DEG C in the stove of the M60/85HA of Nabertherm GmbH company.After described housing is cooling at normal temperatures, the thickness of the coating 120 of described electric insulation has the thickness of 80 μ m+/-2 μ m, and this is rich with Mitutoyo(Japan three) micrometer micrometer caliper measures.Measure subsequently the breakdown voltage of described housing 110.This breakdown voltage is approximately 7kV.Sample, the breakdown voltage of cardiac pacemaker is measured by means of following flow process in this case:
1. contact described housing and described coating with the potentiometric electrode with name of an article WGHP601 of Essen, Germany HCK Electronic GmbH company, this is also referred to as " near contact (ankontaktieren) ";
2. selected minimum possible cut-out electric current, wherein said cut-out electric current is in being less than the scope of 30 μ A;
3. manually improve lentamente described voltage by described potentiometer, until described breakdown voltage.If exceed the cut-out electric current of 30 μ A, reach described breakdown voltage.In this case, described breakdown voltage is 7kV;
4. presetting subsequently 2 lower voltages, utilize described two lower voltages can reach the Check-Out Time of 60 seconds, and do not reach described cut-out electric current.Described voltage 6kV and 6.5kV are selected.
In addition, described potentiometer can detect so-called cut-out electric current.This is the last electric current of measuring, and this electric current detected by described potentiometer before cutting off measuring process.In this special embodiment, described cut-out electric current is approximately 17 μ A.Subsequently described electronic unit 180 is put in one of two shell halfbodies of described housing 110.Described electronic unit 180 is battery 140 and capacitor 130 and electrode in this case.Finally two halfbodies of described housing 110 are sticked together.
In Fig. 4, schematically show for implanting by the flow process of the method for device 100 of the present invention.At this, first step 410 is representing the step that described housing 110 is provided.This can carry out with the form of packaged device 110 or with the form of putting into the device 100 in applicator as described in above.In described second step 420, open described tissue.This can be by additional device, such as blade or scalpel or applicator carry out.In described third step 430, described device 100 is put in described tissue.If relate to cardiac pacemaker or relate to defibrillator, that is such as electrode and heart being coupled together, and described electrode is controlled by described, electronic unit 180 that form by capacitor 130 and battery 140.But described device 100 can be also the instrument of pure diagnosis, such as in the monitoring system of monitoring such as the body function in blood.Can in described closed 440 the 4th step, make described health closure subsequently, if be necessary like this.Described ratio of closing error is as undertaken by adhesive bandage or clamp.
Reference numerals list:
100 devices that can implant
110 housings
The coating of 120 electric insulations
130 capacitors
140 batteries
150 coating surfaces
160 inner surfacies
170 outer surfaces
180 electronic units
210 are coated with the device of application
212 substrates
214 reference coordinates
216 control units
218 liquid phases
220 force applications mechanisms
222 nozzles
224 carrier pipes
226 coating openings
310 first steps: housing is provided
320 second steps: coating
330 third steps: dry
340 the 4th steps: electronic unit is installed
410 first steps: generator
420 second steps: open
430 third steps: be installed in tissue
440 the 4th steps: closure
Claims (20)
1. device (100), it comprises:
-housing (110), described housing has inner surface (160) and outer surface (170);
-electronic unit (130,140,180);
Wherein said housing (110) surrounds described electronic unit (130,140,180) at least in part;
That at least a portion of the inner surface (160) of wherein said housing (110) has is one the polymer that comprises at least 30 weight percent points, electric insulation, be provided with the coating (120) towards the coating surface (150) of described inner surface (160);
Wherein said inner surface (160) and described coating surface (150) interconnect.
2. by device claimed in claim 1 (100), it is characterized in that, described electronic unit comprises capacitor (130).
3. by device claimed in claim 2 (100), wherein said capacitor (130) has the electric capacity the scope in from 50 to 1000 μ F.
4. press device in any one of the preceding claims wherein (100), the titanium that wherein said housing (110) comprises at least 30 weight percent points with respect to described housing.
5. by device in any one of the preceding claims wherein (100), wherein said polymer is selected from the group being made up of following material: acrylates, alkyd resins, polyester-imide, polyamide-imide and silicone or the wherein at least combination of bi-material.
6. by device in any one of the preceding claims wherein (100), wherein said coating (120) has the thickness the scope in from 1 to 100 μ m.
7. by device in any one of the preceding claims wherein (100), the coating (120) of wherein said insulation has in from 1 to 30cm
2scope in area.
8. by device in any one of the preceding claims wherein (100), the breakdown voltage of wherein passing the coating of described insulation is 2kV and higher.
9. for the manufacture of the method for device (100), said method comprising the steps of:
A., the housing (110) with an inner surface (160) and an outer surface (170) is provided;
B. by one, by liquid phase (218), coating polymer, electric insulation (120) that form, that comprise at least 30 weight percent points is coated at least a portion of described inner surface (160);
C. electronic unit (130,140,180) is installed in described housing, wherein said housing (110) surrounds described electronic unit (130,140,180) at least in part.
10. by the method described in last claim, the coating of the coating (120) of wherein said electric insulation is undertaken by the process of selecting a kind of group forming from following process: precipitation or dipping or the combination of the two.
11. by the method described in claim 9 or 10, the coating of wherein said liquid phase (218) is arranged on described inner surface (160) coating opening (226) above by one to be carried out, and wherein described liquid phase (218) is coated on described surface with the form of drop.
12. by the method described in claim 9 or 10, the coating of wherein said liquid phase (218) is arranged on described inner surface (160) coating opening (226) above by one to be carried out, and wherein said coating opening (226) and described surface (160) interconnect by described liquid phase (218).
13. by the method described in any one in claim 9 to 12, and wherein said polymer is selected from the group being made up of following material: the combination of acrylates, alkyd resins, polyester-imide, polyamide-imide and silicone or at least wherein bi-material.
14. by the method described in any one in claim 9 to 13, and the coating (120) of wherein said electric insulation is formed or jointly formed by the two by radiation or convection current.
15. by the method described in any one in claim 9 to 14, and wherein in the described coating of coating (120) before, at least a portion of the inner surface (160) of described housing (110) stands a kind of cleaning process of chemistry.
16. by the method described in claim 15, and the cleaning process of wherein said chemistry is selected from the group being made up of following process: the cleaning of thermokalite, the flushing of carrying out with organic solvent and corrosion or the wherein combination of at least two kinds of processes.
17. by the method described in any one in claim 9 to 16, and wherein in the described coating of coating (120) before, at least a portion of the inner surface of described housing (110) stands a kind of cleaning process of machinery.
18. by the method described in claim 17, and the cleaning process of wherein said machinery is selected from the group being made up of following process: plasma cleaning, blasting treatment and bead clean or the wherein combination of at least two kinds of processes.
19. according to the device (100) obtaining by the method described in any one in claim 9 to 18.
20. for implanting by the method for the device (100) described in claim 1 to 8 or 19 any one, said method comprising the steps of:
-described device is provided;
-open tissue;
-described device is put in opened tissue;
-closed described tissue if desired.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102011116289.9A DE102011116289B4 (en) | 2011-10-19 | 2011-10-19 | Method for producing an implantable device with an insulating layer |
| DE102011116289.9 | 2011-10-19 | ||
| PCT/EP2012/004317 WO2013056811A1 (en) | 2011-10-19 | 2012-10-16 | Implantable device with an insulating layer |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN104039389A true CN104039389A (en) | 2014-09-10 |
| CN104039389B CN104039389B (en) | 2016-06-22 |
Family
ID=47189863
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201280051373.0A Expired - Fee Related CN104039389B (en) | 2011-10-19 | 2012-10-16 | Device that can implant, that there is insulating barrier |
Country Status (4)
| Country | Link |
|---|---|
| US (1) | US20150148876A1 (en) |
| CN (1) | CN104039389B (en) |
| DE (1) | DE102011116289B4 (en) |
| WO (1) | WO2013056811A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106562827A (en) * | 2016-11-10 | 2017-04-19 | 东北大学 | Hydrophilic and antibacterial dental implant system and manufacturing method thereof |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102015201755A1 (en) * | 2015-02-02 | 2016-08-04 | Volkswagen Aktiengesellschaft | Method for applying an insulating layer and electronic component |
| KR20190031783A (en) * | 2017-09-18 | 2019-03-27 | 오스템임플란트 주식회사 | A dental implant comprising polyetheretherketone havnig a surface roughness |
| US11247059B2 (en) | 2018-11-20 | 2022-02-15 | Pacesetter, Inc. | Biostimulator having flexible circuit assembly |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5769874A (en) * | 1996-03-26 | 1998-06-23 | Pacesetter Ab | Active medical implant with a hermetically sealed capsule |
| US20030120320A1 (en) * | 2001-12-20 | 2003-06-26 | Medtronic,Inc. | Implantable medical device having a housing or component case with an insulating material formed thereon, and methods of making same |
| US20060224208A1 (en) * | 2005-04-05 | 2006-10-05 | Bal Seal Engineering Co., Inc. | Medical electronics electrical implantable medical devices |
| CN101018583A (en) * | 2004-08-26 | 2007-08-15 | 巴尔密封工程有限公司 | Electrical conductive path for a medical electronics device |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5221170B1 (en) * | 1986-09-15 | 1995-08-01 | Nylok Fastener Corp | Coated threaded fasteners |
| US5871822A (en) * | 1996-09-26 | 1999-02-16 | Honeywell Inc. | Low emissions method for spray application of conformal coating to electronic assemblies |
| EP2367596A1 (en) * | 2008-10-31 | 2011-09-28 | Medtronic, Inc. | Shunt-current reduction housing for an implantable therapy system |
| US8326426B2 (en) * | 2009-04-03 | 2012-12-04 | Enteromedics, Inc. | Implantable device with heat storage |
| GB2471508A (en) * | 2009-07-02 | 2011-01-05 | Invibio Ltd | Composite enclosure with specific WVTR and impact strength, used in an implantable device |
-
2011
- 2011-10-19 DE DE102011116289.9A patent/DE102011116289B4/en not_active Expired - Fee Related
-
2012
- 2012-10-16 US US14/352,618 patent/US20150148876A1/en not_active Abandoned
- 2012-10-16 WO PCT/EP2012/004317 patent/WO2013056811A1/en active Application Filing
- 2012-10-16 CN CN201280051373.0A patent/CN104039389B/en not_active Expired - Fee Related
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5769874A (en) * | 1996-03-26 | 1998-06-23 | Pacesetter Ab | Active medical implant with a hermetically sealed capsule |
| US20030120320A1 (en) * | 2001-12-20 | 2003-06-26 | Medtronic,Inc. | Implantable medical device having a housing or component case with an insulating material formed thereon, and methods of making same |
| CN101018583A (en) * | 2004-08-26 | 2007-08-15 | 巴尔密封工程有限公司 | Electrical conductive path for a medical electronics device |
| US20060224208A1 (en) * | 2005-04-05 | 2006-10-05 | Bal Seal Engineering Co., Inc. | Medical electronics electrical implantable medical devices |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106562827A (en) * | 2016-11-10 | 2017-04-19 | 东北大学 | Hydrophilic and antibacterial dental implant system and manufacturing method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| US20150148876A1 (en) | 2015-05-28 |
| CN104039389B (en) | 2016-06-22 |
| DE102011116289A1 (en) | 2013-04-25 |
| DE102011116289B4 (en) | 2015-02-26 |
| WO2013056811A1 (en) | 2013-04-25 |
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